Categories
Custom Biologics
About CRO
Core Services
Custom Biologics specializes in GLP-compliant bioanalytical services for biologics, vaccines, and gene therapies across preclinical and clinical development stages. Services include:
- Potency & Functional Assays: Cell-based assays, ELISA, ELISpot, ligand-binding assays
- Genomics & Molecular Testing: ddPCR, qPCR, RT-qPCR, DASL-Rapid™ for rapid pathogen detection
- Analytical Testing: Western blot, BLI, SDS-PAGE, mass spectrometry
- GMP Testing: Lot release, stability, identity/purity testing
- Regulatory Support: Assay development, validation, and tech transfer aligned with FDA 21 CFR Part 58 and Part 11
Specialization Areas
- Gene Therapy: AAV, lentivirus, oncolytic virus characterization
- Immunogenicity & Pharmacokinetics: Assessments for biologics and biosimilars
- Cell & Gene Therapies: Support from discovery through clinical trials
- Regulatory Compliance: Health Canada Drug Establishment License; ISO 13485 compliant
Facility & Quality Assurance
Custom Biologics operates an 8,000 sq. ft. GLP-compliant facility at 115 Skyway Ave, Toronto. Their quality system follows FDA and EMEA GLP guidelines to ensure data integrity and regulatory compliance.
Leadership Team
- Dan Mamelak, PhD – Founder & President
- Kalhari Silva, PhD – Head of Scientific Research & Innovation
- Carolyn Modi – Quality Assurance Manager
Global Reach & Clientele
With over 20 years of experience, Custom Biologics has supported more than 200 preclinical and clinical studies for over 125 clients worldwide, including major pharmaceutical and biotech companies.
Contact Information
Phone: +1 (416) 479-3773
Email: info@custombiologics.com
Website: https://www.custombiologics.com/
Social Media
LinkedIn: https://www.linkedin.com/company/custombiologics
Twitter: https://x.com/custmbio
Technology & Expertise
At Custom Biologics, we draw on over 20 years of large‑molecule bioanalytical experience to support biologics, vaccines, cell and gene therapies. Our scientists specialize in functional assays (cell‑based, ligand/receptor binding), pharmacokinetic/toxicokinetic quantification, immunogenicity evaluation and genomics methods for gene‑therapy vectors and transgenes.
Core Services
We offer a comprehensive suite of services that includes assay development and validation (for potency, mechanism of action, and bioactivity), stability and lot‑release testing, pharmacokinetics and immunogenicity studies, and molecular/genetic analyses. Whether for discovery, CMC, or clinical phases, our services are designed for full regulatory submission support.
Accreditations & Compliance
Our operations are run under a rigorous quality system aligned with GLP and regulatory expectations—our independent Quality Assurance Unit ensures adherence to 21 CFR Part 11 and Part 58 guidelines. We also maintain a Canadian GMP Drug Establishment Licence, reinforcing our global compliance readiness.
What services does Custom Biologics provide?
Custom Biologics offers GLP-compliant bioanalytical and molecular testing services for biologics, vaccines, and gene therapies. Our capabilities span potency and functional assays, genomics and molecular testing, analytical characterization, GMP testing, and regulatory assay validation.
What industries and therapeutic areas do you support?
We support pharmaceutical, biotechnology, and academic clients engaged in biologics, biosimilars, vaccines, and gene therapy development. Our experience includes AAV and lentiviral vector characterization, oncolytic virus studies, and immunogenicity assessments.
Are your laboratories GLP and GMP compliant?
Yes. Custom Biologics operates an 8,000 sq. ft. facility in Toronto that is GLP-compliant and follows FDA and EMEA Good Laboratory Practice guidelines. We also perform GMP testing, including lot release, stability, and identity/purity assessments.
What molecular testing platforms do you use?
Our molecular testing capabilities include ddPCR, qPCR, RT-qPCR, and the proprietary DASL-Rapid™ platform for rapid pathogen detection and vector genome quantification.
